[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-tombak-llc-720496-01222026":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":15,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":8,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},323,"tombak-llc-720496-01222026","Warning Letter","Tombak LLC",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2026-02-24","2026-01-22","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ftombak-llc-720496-01222026","ER2601410","720496","Tobacco","VIA UPS and Electronic Mail","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA UPS and Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">ER2601410\u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Tobacco                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>Tombak LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">10 South Havana Street, Suite 119R\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Aurora\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CO\u003C\u002Fspan> \u003Cspan class=\"postal-code\">80012\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Tobacco Products\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>To Whom It May Concern:\u003C\u002Fp>\u003Cp>The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed our inspection records and https:\u002F\u002Ftombakllc.com and determined that the smokeless tobacco products listed there are manufactured and offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including smokeless tobacco products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)). Therefore, smokeless tobacco is required to be in compliance with the requirements in the FD&C Act.\u003C\u002Fp>\u003Cp>\u003Cstrong>New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>FDA has determined that you manufacture, import and offer for sale or distribution to customers in the United States the following smokeless tobacco products that lack a marketing authorization order: Tombak Loose Leaf Chewing Tobacco, unflavored.\u003C\u002Fp>\u003Cp>The FD&C Act requires “new tobacco products” to have premarket authorization. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)).\u003C\u002Fp>\u003Cp>The tobacco product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, it is misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act.\u003C\u002Fp>\u003Cp>\u003Cstrong>Modified Risk Tobacco Product Violation(s)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Additionally, our review of https:\u002F\u002Ftombakllc.com, marketing pamphlet, and product label revealed that you manufacture, sell or distribute the following smokeless tobacco product, which is described as presenting a lower risk of tobacco-related disease: Tombak Loose Leaf Chewing Tobacco, unflavored. Specifically, both https:\u002F\u002Ftombakllc.com, marketing pamphlet, and the product label contain the following claim: “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.”\u003C\u002Fp>\u003Cp>A tobacco product is considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that: (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).\u003C\u002Fp>\u003Cp>The above listed product is a modified risk tobacco product because the labeling and advertisement describes it as presenting a lower risk of tobacco-related disease or being less harmful than one or more other commercially marketed tobacco products. Because this product is sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), this product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).\u003C\u002Fp>\u003Cp>\u003Cstrong>Health Warning Statement Violation(s)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Additionally, our review of https:\u002F\u002Ftombakllc.com and marketing pamphlet revealed that the following smokeless tobacco product that you offer for sale or distribution in the United States does not include the required health warning statements: Tombak Loose Leaf Chewing Tobacco, unflavored. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act, requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:\u003C\u002Fp>\u003Cp>WARNING: This product can cause mouth cancer.\u003C\u002Fp>\u003Cp>WARNING: This product can cause gum disease and tooth loss.\u003C\u002Fp>\u003Cp>WARNING: This product is not a safe alternative to cigarettes.\u003C\u002Fp>\u003Cp>WARNING: Smokeless tobacco is addictive.\u003C\u002Fp>\u003Cp>Because your website and pamphlet regarding smokeless tobacco products does not include the required health warnings, your smokeless tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and\u002For section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).\u003C\u002Fp>\u003Cp>In addition, we note that you are required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402) requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion and Requested Actions\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violation that are referenced above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.\u003C\u002Fp>\u003Cp>It is your responsibility to ensure that your tobacco products and all related labeling and\u002For advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in this publication, any other publication, and in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the type described above may result in FDA initiating action, including, but not limited to, civil money penalties, seizure, and\u002For injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that adulterated and\u002For misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.\u003C\u002Fp>\u003Cp>Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and\u002For distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at http:\u002F\u002Fwww.fda.gov.\u003C\u002Fp>\u003Cp>Please note your reference number, ER2601410, in your response and direct your response to the following address:\u003C\u002Fp>\u003Cp>DEM-WL Response, Office of Compliance and Enforcement  \u003Cbr>FDA Center for Tobacco Products  \u003Cbr>c\u002Fo Document Control Center  \u003Cbr>Building 71, Room G335  \u003Cbr>10903 New Hampshire Avenue  \u003Cbr>Silver Spring, MD 20993-0002\u003C\u002Fp>\u003Cp>If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>John E. Verbeten\u003Cbr>Director\u003Cbr>Office of Compliance and Enforcement\u003Cbr>Center for Tobacco Products\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA UPS and Electronic Mail\n\nReference #:\n\nER2601410\n\nProduct:\n\nTobacco\n\nRecipient:\n\nTombak LLC\n\n10 South Havana Street, Suite 119R\n\nAurora, CO 80012\n\nUnited States\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nWARNING LETTER\nTo Whom It May Concern:\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed our inspection records and https:\u002F\u002Ftombakllc.com and determined that the smokeless tobacco products listed there are manufactured and offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including smokeless tobacco products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)). Therefore, smokeless tobacco is required to be in compliance with the requirements in the FD&C Act.\nNew Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded\nFDA has determined that you manufacture, import and offer for sale or distribution to customers in the United States the following smokeless tobacco products that lack a marketing authorization order: Tombak Loose Leaf Chewing Tobacco, unflavored.\nThe FD&C Act requires “new tobacco products” to have premarket authorization. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)).\nThe tobacco product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, it is misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act.\nModified Risk Tobacco Product Violation(s)\nAdditionally, our review of https:\u002F\u002Ftombakllc.com, marketing pamphlet, and product label revealed that you manufacture, sell or distribute the following smokeless tobacco product, which is described as presenting a lower risk of tobacco-related disease: Tombak Loose Leaf Chewing Tobacco, unflavored. Specifically, both https:\u002F\u002Ftombakllc.com, marketing pamphlet, and the product label contain the following claim: “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.”\nA tobacco product is considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that: (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).\nThe above listed product is a modified risk tobacco product because the labeling and advertisement describes it as presenting a lower risk of tobacco-related disease or being less harmful than one or more other commercially marketed tobacco products. Because this product is sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), this product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).\nHealth Warning Statement Violation(s)\nAdditionally, our review of https:\u002F\u002Ftombakllc.com and marketing pamphlet revealed that the following smokeless tobacco product that you offer for sale or distribution in the United States does not include the required health warning statements: Tombak Loose Leaf Chewing Tobacco, unflavored. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act, requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:\nWARNING: This product can cause mouth cancer.\nWARNING: This product can cause gum disease and tooth loss.\nWARNING: This product is not a safe alternative to cigarettes.\nWARNING: Smokeless tobacco is addictive.\nBecause your website and pamphlet regarding smokeless tobacco products does not include the required health warnings, your smokeless tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and\u002For section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).\nIn addition, we note that you are required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402) requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA.\nConclusion and Requested Actions\nThe violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violation that are referenced above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.\nIt is your responsibility to ensure that your tobacco products and all related labeling and\u002For advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in this publication, any other publication, and in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the type described above may result in FDA initiating action, including, but not limited to, civil money penalties, seizure, and\u002For injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that adulterated and\u002For misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.\nPlease submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and\u002For distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at http:\u002F\u002Fwww.fda.gov.\nPlease note your reference number, ER2601410, in your response and direct your response to the following address:\nDEM-WL Response, Office of Compliance and Enforcement\nFDA Center for Tobacco Products\nc\u002Fo Document Control Center\nBuilding 71, Room G335\n10903 New Hampshire Avenue\nSilver Spring, MD 20993-0002\nIf you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.\nSincerely,\n\u002FS\u002F\nJohn E. Verbeten\nDirector\nOffice of Compliance and Enforcement\nCenter for Tobacco Products","2026-08-19T04:57:36.686+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-02-24T05:00:00Z\">02\u002F24\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-01-22T05:00:00Z\">01\u002F22\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ftombak-llc-720496-01222026\">Tombak LLC\u003C\u002Fa>","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]